The goal of clinical trial is to assess an integrated, patient-centered strategy combining user preference-based prosthetic foot prescription and subsequent targeted physical therapy to maximize satisfaction and mobility outcomes for Veterans and others with lower limb loss. The main aims it will address are: * Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction * Assess the effect of a targeted physical therapy intervention following preference-based foot selection on mobility, balance, and satisfaction? Participants will walk with an emulator prosthetic foot to experience three different conditions that emulate different commercial feet to determine their most- and least-preferred foot. Participants' satisfaction, perceived mobility, and functional mobility will be measured and compared between their most- and least-preferred feet using the corresponding commercial feet. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized physical therapy intervention for eight weeks using that preferred prosthetic foot. Participants' satisfaction, mobility, and balance will be measured pre- and post-intervention.
Aim 1: Assess the effect of prosthetic foot selection based on experiential preference as determined using a variable stiffness foot on mobility and satisfaction. Baseline mobility and satisfaction of 50 Veterans with unilateral transtibial amputation (UTTA) will initially be evaluated with their currently prescribed prosthesis. Participants will then walk with the Variable-Stiffness Prosthetic Ankle (VSPA) Foot across real-world mobility scenarios inside and outside the laboratory. During this protocol, participants will experience three different VSPA Foot conditions that emulate different commercial feet to determine each participant's most- and least-preferred foot (with further opportunity for fine-tuning to determine the optimal stiffness category of their most preferred foot). Participants' satisfaction, perceived mobility, and functional mobility will be measured and compared between their most- and least-preferred feet using the corresponding commercial feet. Aim 2: Assess the effect of a targeted physical therapy (PT) intervention following preference-based foot selection on mobility, balance, and satisfaction. After a two-week, community-based accommodation period with their most preferred commercial foot, participants' satisfaction, perceived and functional mobility, and balance will be measured. Participants will then be randomly assigned to receive either the standard-of-care (control group) or personalized PT intervention that targets and addresses impairments in mobility and balance and patient-specific functional goals (intervention group). Following eight weeks of either standard-of-care or PT intervention, participants' satisfaction, mobility, and balance will again be measured and compared between groups (intervention vs. control) and across time periods (pre- vs. post-accommodation measurements).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The most- and least-preferred prosthetic foot
Personalized physical therapy
Northwestern University Prosthetics-Orthotics Center
Chicago, Illinois, United States
Trinity Amputation and Prosthesis Experience Scales - Satisfaction
Patient-reported outcome measure that assesses functional satisfaction with the prosthesis. The maximum value is 15 and the minimum value is 5, with higher better scores meaning a better outcome. This sum score (max 15) is used for reporting and analysis.
Time frame: From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
Prosthetic Limb Users' Survey of Mobility
Patient-reported outcome measure that measures perceived mobility with a prosthesis. The maximum value is 60 and the minimum value is 12, with higher better scores meaning a better outcome. Scores are converted to t-scores for reporting and analysis.
Time frame: From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
Activities-specific Balance Confidence Scale
Patient-reported outcome measure that measures perceived balance confidence. The maximum value is 60 and the minimum value is 0, with higher better scores meaning a better outcome. Scores are converted to an average through dividing the sum by number of tasks (15) for reporting and analysis.
Time frame: From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
Timed up and go
Performance-based outcome measure that measures walking ability and dynamics balance. The time taken to complete the task is recorded as the score and less time means a better outcome.
Time frame: From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
Four square step test
Performance-based outcome measure that measures dynamics balance. The time taken to complete the task is recorded as the score and less time means a better outcome.
Time frame: From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
Amputee Mobility Predictor
Performance-based outcome measure that measures gait and balance. Each task is scored on an ordinal scale, and the maximum value is 47 and the minimum value is 0, with higher better scores meaning a better outcome.
Time frame: From enrollment (baseline) to the end of the eght week physical therapy intervention or at the time of withdrawal, whichever comes first, assessed up to 5 months
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